Big food awaits new FDA rules

Now that the FDA has crossed trans fat off its to-do list, look for three big food regulatory changes to come soon from the agency: menu labeling, nutrition facts and sodium.

The FDA’s Center for Food Safety and Applied Nutrition’s 2013-14 plan outlines an almost dizzying list of priorities, and after the policy freeze that preceded the 2012 election, several of them are on the move. The agency has met many of its 2013 goals, including issuing an acrylamide guidance, settling on a definition of “gluten-free,” setting action levels for arsenic in apple juice and publishing the most significant Food Safety Modernization Act rules.

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But with just a month to go in the year, many of the initiatives planned for 2013 have yet to arrive, including developing policy options for energy drinks, issuing updated fish consumption advice and releasing a final guidance for manufacturers who want to voluntarily label their products with or without genetically engineered ingredients.

The FDA is also under a court order to get its last two big FSMA rules out in the next two months, one addressing intentional adulteration due Dec. 20; the other on the sanitary transport of food due Jan. 31. Michael Taylor, deputy commissioner for foods and veterinary medicine, has said publicly that the FDA intends to meet the Dec. 20 deadline for intentional adulteration, so that is likely to be the next policy announcement to come from the agency.

But when might FDA release any of these other food-related rules or guidances?

“It is impossible to predict,” said Joseph Levitt, a 25-year veteran of the FDA, now a partner at Hogan Lovells. “The one exception is FSMA, because FDA appears to be pulling out all the stops to meet the court deadlines.”

“Even people on the inside don’t know,” said Levitt, who directed all FDA’s food safety-related operations for six years, because there are so many levels of clearance involved. “The final dates are not within their control.”

However, there are three items, in particular, to watch for in the coming months:

Menu Labeling

It has been a year and a half since the FDA issued a proposed rule to require calorie labeling on the menus used by chain restaurants and “similar retail food establishments” — as called for by the Affordable Care Act — and set off a fiery battle that pitted convenience and grocery stores and pizza chains against the restaurant industry and consumer groups over what establishments should be covered.

FDA Commissioner Margaret Hamburg has said publicly that the menu labeling rule has proved much more complicated than expected. At an event last month, Hamburg said to expect a final rule “soon,” but otherwise stakeholders have been left guessing about what the agency will decide or when an announcement might be made.

“If you have a magic eight ball, shake it up,” said Greg Ferrara, vice president of public affairs at the National Grocers Association, which represents privately owned grocery stores. Groups have been hearing that the rule is imminent for months, Ferrera said. “It’s a mystery to us.”

But everyone, from the National Grocers Association to the American Pizza Community and the Center for Science in the Public Interest, a consumer advocacy group, is anxious to see what FDA decides.

“It’s one of our top priorities right now,” Ferrera said.

“To say there is anticipation is probably an understatement,” said Scott DeFife, executive vice president of policy and government affairs for the National Restaurant Association, who expects the final rule soon.

“There’s a lot of chatter about the regulations being done and ready to move,” he said. “It wouldn’t surprise me if they released them within the next 45 to 90 days.”

Menu labeling also is one of Rep. Rosa DeLauro’s most important FDA-related priorities for the agency, and she wants to see the rule broadly applied.

“Commissioner Hamburg has a number of big issues in front of her, most notably finalizing the menu label requirements,” the Connecticut Democrat told POLITICO in a statement. “This step to enhance transparency was passed into law over three years ago, and I am hopeful that we will soon see a strong final rule that includes restaurants, stores and movie theaters.”

Nutrition Facts Update

The agency has been working on updating the nutrition facts panel — which hasn’t fundamentally changed since it was first created in 1993 — for years, but the FDA is rumored to be close to releasing its proposal, perhaps as early as January.

“This is something that’s been in the works since I was there — and I left 10 years ago,” Levitt said.